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BRIEF TITLE: Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

  • Org Study ID: 2018-01
  • Secondary ID:
  • NCT ID: NCT03662204
  • NCT Alias:
  • Sponsor: Exact Sciences Corporation - Industry
  • Source: Exact Sciences Corporation

Brief Summary

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

Detailed Description

Subjects who have been diagnosed, or who have a suspicion of diagnosis based on imaging, with
any solid tumor. Subjects will have a blood sample collected at enrollment and provide
medical history prior to initiation of treatment. There will be no further follow-up.

Overal Status Start Date Phase Study Type
Recruiting August 23, 2018 Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Biomarker Evaluation

Primary Outcome 1 - Time Frame: Point in time (one day) blood collection at enrollment


  • Breast Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • Bladder Cancer
  • Uterine Cancer
  • Kidney Cancer
  • Renal Pelvis Cancer
  • Pancreatic Cancer
  • Liver Cancer
  • Stomach Cancer
  • Ovarian Cancer
  • Esophageal Cancer


Inclusion Criteria:

1. Subject is male or female > 18 years of age.

2. Subject has an untreated primary malignancy of breast, lung, colorectal, prostate,
bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or<br/> esophageal cancer.


Subject has suspicion of a primary malignancy of bladder, kidney/renal pelvis, or
ovarian cancer based on imaging.

3. Subject understands the study procedures and is able to provide informed consent to
participate in the study and authorization for release of relevant protected health
information to the study Investigator.

Exclusion Criteria:

1. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal
cell or squamous cell skin cancers).

2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample

3. Any treatment for the primary malignancy or sites of metastases. Subject may not have
started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or
other treatment and/or surgery prior to blood sample collection.

4. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood

5. Less than 7 days between biopsy (other than FNA) of target pathology and blood

6. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.

7. Individual has a condition the Investigator believes would interfere with his or her
ability to provide informed consent, comply with the study protocol, which might
confound the interpretation of the study results or put the person at undue risk.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Alexandra Massoud

Phone: 608-957-5652



Facility Status Contact
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Lowcountry Urology/PMG Research of Charleston, LLC
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PMG Research of Bristol, LLC
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Sun Research Institute
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Urology of Virginia, PLLC
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